The following data is part of a premarket notification filed by Chemtron Biotech, Inc. with the FDA for Chemtrue(r) Hcg Pregnancy Urine Midstream Test.
| Device ID | K131931 |
| 510k Number | K131931 |
| Device Name: | CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | CHEMTRON BIOTECH, INC. 8370 JUNIPER CREEK LANE SUITE 1-2 San Diego, CA 92126 |
| Contact | Jane Zhang |
| Correspondent | Jane Zhang CHEMTRON BIOTECH, INC. 8370 JUNIPER CREEK LANE SUITE 1-2 San Diego, CA 92126 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-27 |
| Decision Date | 2013-07-26 |
| Summary: | summary |